SILTRAX EPI 9 GINGIVAL RETRACTION CORD *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1998-01-16 for SILTRAX EPI 9 GINGIVAL RETRACTION CORD * manufactured by Pascal Co., Inc..

Event Text Entries

[82889] Around 9:00 am, january 2, 1998 dr packed two teeth with siltrax epi 9 cord, batch #020100. She packed a total of 1. 5 inches. Prior to packing the cord the dentist asked her if she was on any medication or had any heart problems or hypertension problems and she was told no. About 12:30 pm of the same day the pt called complaining of nausea, dizziness and nervousness. The dentist knew that the pt had worked the night shift the night before, had not slept since working, and had not eaten any breakfast so she thought that she may have low blood sugar so she told her to take some orange juice. She had only a cup of tea between leaving the dentist's office and the onset of symptoms. The dentist called back a few mins later and the symptoms did not pass and she told the pt to go to a hosp er. The pt thought that this was unnecessary so the dentist talked to her son and told him to take her no matter what. She was taken to emergency and pulse and blood pressure were normal. Her electrocardiogram was taken but they wanted to compare it to her earlier electrocardiogram to see if it was abnormal. When comparing it, they found it abnormal. The er dr diagnosed it as cardiac ascemia. Her cardiac enzymes were normal also. As of the evening of january 3, her electrocardiogram was normal. They are keeping her in the hosp and plan to do a stress test today, january 5. Pt described as skinny as a rail by dr. Other notes: she was laid off work at a hosp over a mo ago and, after much negotiations, she got her job only now she had to work the night shift instead of the day shift. She had worked 6 nights in row prior to her dentist visit. The dentist described her as "skinny as a rail. " pt released from hosp on 1/7/98. Pt is still week.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3011632-1998-00001
MDR Report Key188570
Report Source05
Date Received1998-01-16
Date of Report1998-01-16
Date of Event1998-01-02
Date Mfgr Received1998-01-02
Date Added to Maude1998-09-25
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationDENTIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSILTRAX EPI 9 GINGIVAL RETRACTION CORD
Generic Name*
Product CodeMVL
Date Received1998-01-16
Model Number*
Catalog Number*
Lot Number020100
ID Number*
Device Expiration Date2000-02-01
Device Availability*
Device Eval'ed by Mfgr*
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key183264
ManufacturerPASCAL CO., INC.
Manufacturer AddressP.O. BOX 1478 BELLEVUE WA 980091478 US


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 1998-01-16

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